Completed

A Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma

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What is being tested

Data Collection

Who is being recruted

DNA Virus Infections
+7

+ Herpesviridae Infections
+ Infections
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2005
See protocol details

Summary

Principal SponsorAIDS Malignancy Consortium
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2005Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the safety of valproic acid in patients with Kaposi's sarcoma. * Determine the effects of this drug on human herpes virus 8 (KSHV) gene expression using polymerase chain reaction and immunohistochemistry in these patients. Secondary * Determine the effects of this drug on HIV, KSHV, and Epstein-Barr virus viral loads in the plasma and peripheral blood mononuclear cells of these patients. * Determine clinical response in patients treated with this drug. OUTLINE: This is an open-label, pilot, multicenter study. Patients receive oral valproic acid twice daily on days 1-28 followed by a drug taper over 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1 year.

Official TitleA Pilot Trial Of Valproic Acid In Patients With Kaposi's Sarcoma 
NCT00075777
Principal SponsorAIDS Malignancy Consortium
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
19 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
DNA Virus Infections
Herpesviridae Infections
Infections
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Sarcoma
Sarcoma, Kaposi
Virus Diseases
Neoplasms, Connective and Soft Tissue
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed HIV-related Kaposi's sarcoma (KS) * Disease involving the skin and/or lymph nodes * No symptomatic visceral disease * No oral KS as the only site of disease * Slowly progressive or stable disease allowed * Slow progression defined as fewer than 5 new lesions per month * Must have documented HIV infection by positive ELISA, western Blot, or viral load determination * CD4 T-cell count \> 50/mm\^3 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * At least 3 months Hematopoietic * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count ≥ 750/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN)\* * AST and ALT ≤ 3 times ULN * Albumin \> 2.5 g/dL NOTE: \*Elevated total bilirubin (≤ 3.5 mg/dL) secondary to indinavir therapy allowed provided the direct bilirubin is normal Renal * Creatinine \< 1.5 times ULN Cardiovascular * No prior myocardial infarction * No evidence of cardiac ischemia Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No prior lactic acidosis \> 2.0 mmoles/L * No prior lipoatrophy or hypercholesterolemia secondary to retroviral treatment * No concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within the past 14 days * No other concurrent neoplasm requiring cytotoxic therapy PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior biologic therapy for KS Chemotherapy * More than 2 weeks since prior chemotherapy for KS * No concurrent systemic cytotoxic chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 2 weeks since prior radiotherapy for KS Surgery * Not specified Other * More than 2 weeks since other prior antineoplastic or local therapy for KS * More than 2 weeks since prior investigational therapy for KS * More than 60 days since prior local therapy to a KS-marker lesion unless lesion has clearly progressed since therapy * More than 1 year since prior valproic acid * Concurrent antiretroviral therapy allowed provided regimen has been stable for at least 4 weeks * No concurrent zidovudine * No other concurrent KS-specific therapy * No other concurrent investigational drugs, other than IND-approved antiretroviral agents


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 13 locations
Suspended
Jonsson Comprehensive Cancer Center at UCLALos Angeles, United StatesSee the location
Suspended
Veterans Affairs Medical Center - San DiegoSan Diego, United States
Suspended
UCSF Comprehensive Cancer CenterSan Francisco, United States
Suspended
Georgia Cancer Center for Excellence at Grady Memorial HospitalAtlanta, United States

Completed13 Study Centers
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